Received Date : 19-Sep-2014
Accepted Article
Accepted Date : 10-Feb-2015 Article type
: Review Article
The surgical management of recurrent stress urinary incontinence: a systematic review
Running headline: The surgical management of recurrent SUI
Kostis I. Nikolopoulos1, Cornelia Betschart2 & Stergios K. Doumouchtsis1
1
Urogynaecology Unit, Department of Obstetrics and Gynaecology, St. George’s Healthcare
NHS Trust, St George’s University of London, London, UK 2
Department of Gynecology, University Hospital Zurich, Zurich, Switzerland
Corresponding Author: Kostis I. Nikolopoulos Urogynaecology Unit, Department of Obstetrics and Gynaecology, St. George’s Healthcare NHS Trust, St George’s University of London, Cranmer Terrace, London SW17 0RE, UK Email: [email protected]
Conflict of interest: This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/aogs.12625 This article is protected by copyright. All rights reserved.
K. Nikolopoulos and C. Betschart declare no conflict of interest. S. Doumouchtsis has received speaker honoraria and honoraria for participation in scientific meetings from
Accepted Article
Astellas, Pfizer and Speciality European Pharma, and has been a member of the advisory board of Speciality European Pharma.
Abstract Background: Despite a wide spectrum of interventions, surgical treatments of recurrent stress urinary incontinence (SUI) are associated with high failure rates. Objectives: To systematically review current evidence on the effectiveness of surgical interventions for recurrent SUI. Data sources: An electronic database search was undertaken (1980-2014). Keywords were: 'stress urinary incontinence', 'failure', 'recurrence', 'treatment'. References of identified studies and abstracts from conferences were considered. Study selection: We restricted the search to female patients and currently used surgical procedures, including studies with ≥5 cases. After the initial yield, studies were selected following title screening, abstract and full text scrutiny. Results: The pooled objective cure rates of colposuspension for recurrent SUI are 76% (95%CI: ±5.04), whereas rates for midurethral sling procedures are 68.5% (95%CI: ±3.11). Repeat midurethral sling procedures have pooled success rates of 66.2% (95%CI: ±4) but those of the transobturator approach appear lower than retropubic procedures. Pubovaginal slings for recurrent SUI, have pooled success of 79.3% (95%CI: ±6.54). Success rates for adjustable continence therapy and adjustable slings for recurrent SUI are 53.8% (95%CI: ±5.28), whereas for midurethral sling procedures fixation the pooled success is 61% (95%CI: ±10.56). Urethral bulking injections have success rates of 38% (95%CI:±10.7). Laparoscopic two-team sling procedures, salvage spiral slings and artificial urinary sphincter have shown promising results, but there is limited data on recurrent cases. Conclusion: There is a wide spectrum of surgical interventions reported for secondary or tertiary treatment of SUI. A common characteristic for all recurrent procedures is a lower success rate compared to those reported following primary procedures.
Keywords: stress urinary incontinence, midurethral sling, failure, recurrence, treatment.
Abbreviations and Acronyms
This article is protected by copyright. All rights reserved.
Adjustable Single-Incision Sling System
CI
confidence intervals
GRADE
Grading of Recommendations Assessment, Development, and Evaluation
MUS
midurethral sling procedures,
OCEBM
Oxford Centre for Evidence-based Medicine Levels of Evidence
SUI
stress urinary incontinence,
TOT
transobturator tape outside in,
TVT
tension-free vaginal tape,
TVT-O
transobturator tape inside out,
Accepted Article
AJUST®
Key Message Several different procedures can be considered for recurrent stress urinary incontinence, however, they are associated with lower success rates than those of the first surgery.
Introduction
The reported prevalence of stress urinary incontinence (SUI) can be as high as one in five adult women and approximately half of all incontinent women are affected by this type of incontinence (1). Many surgical procedures are used for the treatment of SUI. In spite of the wide spectrum of options available, treatment fails in 10-20% of patients (2). In the United States alone, about 120 000 women undergo surgery for urinary incontinence each year (3), so the expected absolute numbers of women with failures and recurrences as well as recurrent procedures are high. The persistence of symptoms after surgery for recurrent SUI is common. Since the introduction of the tension-free vaginal tape (TVT) in 1995, more than 1 200 000 procedures have been performed worldwide (4). However, the treatment of recurrent SUI after failed midurethral sling procedures (MUS) is a challenging problem. Although several studies have been published, to date there is no general consensus on the procedure of choice for treating recurrent SUI. A Cochrane review has recently evaluated the treatment of recurrent SUI after failed minimally invasive synthetic suburethral tape placement and found that there are no data to recommend or refute any of the different management strategies for recurrent or persistent SUI after failed suburethral tape surgery (5). In a recent meta-analysis from Agur et al., TVT and transobturator tape outside in (TOT) showed similar patientreported and objective cure rates for the treatment of recurrent SUI and both interventions This article is protected by copyright. All rights reserved.
had a comparable risk of further surgical procedures (6). We aimed to evaluate the current literature on the outcomes of secondary procedures, for the management of recurrent SUI
Accepted Article
after different types of primary surgical procedures.
Material and methods
Sources An electronic search strategy was developed for medical literature databases, the Cochrane Library 2014, PubMed (1950–2014), and Embase (1980–2014), and all searches were updated in May 2014. Google, Google Scholar and congress proceedings were also searched till 05/2014. The keywords and combinations that were used were ‘stress urinary incontinence’, ‘recurrence’, ‘treatment’ and ‘failure’. In addition, references of articles identified were checked for eligibility. We restricted the search to humans and female patients, but no other filters were applied. We also excluded studies involving not currently used surgical procedures. Studies that were finally selected for inclusion were evaluated on the basis of their methodological quality and time of follow-up. We did not specify any limit for the duration of follow-up. In our study design we followed the PRISMA guidelines for systematic reviews and we ensured compliance by completing the PRISMA checklist (7). We further assessed the quality of the selected studies using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria (8).
In order to diminish the subjectivity of the assessment of studies as much as possible, two authors (K.N. and C.B,) classified the quality of evidence independently. Any discrepancies were discussed and if no agreement could be reached, the third author (S.D.) made the final decision.
The objective of this article was to evaluate the success rates following surgical management of recurrent SUI. We undertook a systematic review of the literature and assessment of methodological quality of the qualifying studies. The significant heterogeneity of the selected studies, and the variation in the outcome measures did not allow us to undertake a metaanalysis.
Study selection was undertaken in three stages. First, the titles and then the abstracts of all retrieved articles were examined independently by the researchers. We subsequently This article is protected by copyright. All rights reserved.
examined the full text of each article, and for inclusion, we used an arbitrary cut-off of articles with at least five cases reported. The third step was scrutiny of full-text articles where
Accepted Article
inclusion criteria were met. Reference lists of these studies were also reviewed to identify any publications missed from the initial search (Figure 1).
Data extraction Information was extracted from each included study on: 1) number of cases and characteristics of trial participants, the level of evidence (Oxford levels, see below) and quality of evidence assessment (GRADE), 2) type of initial and secondary intervention, 3) internal bias, 4) type of outcome measure, defined in objective outcome parameters or patient-reported parameters or both, 5) success rates, while 6) 95% confidence intervals (CI) for proportions were calculated for each study, as well as 7) complication rates and 8) time of follow-up (Table 1).
Trial characteristics, outcome measures, success rates, complication rates and follow-up times, based on the Cochrane risk of bias tool, were independently extracted. The high heterogeneity of the retrieved data, as evident in Table 1, restricted the analysis.
Studies, reporting on outcomes of surgical treatment for recurrent SUI with insufficient information for assessment, especially on success rates, have been excluded. A number of randomized controlled trials on surgical management of SUI, which reported on the outcome of surgical management of recurrent SUI, were not included, because these publications did not specify which of the cases were recurrent and therefore identification of such cases or pooling of data was not possible (9-13).
Quality assessment Articles meeting the selection criteria were assessed for methodological quality, level of evidence (Oxford Centre for Evidence-based Medicine Levels of Evidence (OCEBM) www.cebm.net/oxford-centre-evidence-based-medicine-levels-evidence-march-2009/)), including factors likely to influence results. The 95%CI was calculated for each study as well as for pooled results. Factors assessed included prospective design, consecutive recruitment, adequate description of cases included and procedures undertaken, complete reporting of outcomes, complications and time of follow-up (Table 1). In addition we assessed the included studies with the following criteria, based on the GRADE approach which is This article is protected by copyright. All rights reserved.
considered by several organizations as a methodologically rigorous, user-friendly grading system (14). According to GRADE, the quality of evidence is divided into four categories:
Accepted Article
high, moderate, low, and very low. For each study, evidence quality was assessed according to GRADE and included five domains: study design, risk of bias, inconsistency, indirectness and imprecision. Because all the studies included in this review are observational studies, the initial assessment was ‘low’ level of quality.
Risk of bias was assessed for each study, taking into account the time of follow-up, and the outcome measures-definition of success. Objective outcome parameters are the cough test, no urinary leakage during urodynamics or different kinds of pad tests. Subjective or patientreported outcome parameters were the severity and impact of incontinence symptoms assessed by specific questionnaires.
The third domain, inconsistency, was also described as heterogeneity of results without a plausible explanation, based on differences in populations, interventions or outcomes. When group differences appeared (such as studies which do not report exact numbers of patients who had undergone an initial procedure when the initial procedure was variable, or which MUS were used, i.e. TVT or TOT), the quality rating was downgraded.
Indirectness could refer to indirect comparisons. As we did not include studies comparing two different interventions for the surgical management of recurrent SUI, indirectness was not applicable in this review.
The fifth domain, imprecision of results, referred to wide 95%CIs as a consequence of few participants or few events. The quality of evidence was downgraded in the case of a nonsignificant result (8).
Results
Our review revealed a wide spectrum of surgical techniques used for secondary or tertiary treatment of recurrent SUI. Procedures such as Burch colposuspension, retropubic MUS (TVT), transobturator tapes (TOT, transobturator tape inside out (TVT-O)), bladder neck injections and artificial urethral sphincter, have most commonly been reported (Table 1). This article is protected by copyright. All rights reserved.
Burch colposuspension
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Seven studies on Burch colposuspension for recurrent SUI have reported in total 276 cases, with a 76% overall success rate (95%CI: ±5.04) (15-21). According to Amaye-Obu et al. who studied 26 patients, the Burch procedure had a cure rate of 81% (95%CI: ±15.08) when it was carried out after one previous failed procedure (any procedure), 25% when it was done after two previous surgeries, and 0% after three previous procedures at a two year follow-up. They suggested that the Burch procedure should be avoided after more than one previous operation (p=0.001) (15). Similar success rates were reported by Maher et al. for Burch colposuspension after various index procedures, with objective cure rates of 81.1% (43/53 patients) (16). Two other studies on open colposuspension for failed continence procedures reporte objective and subjective cure rates to be 78 - 80% and 71 - 80%, respectively (17,18).
In two small retrospective studies of 13 and 16 patients who underwent open and laparoscopic Burch colposuspension after failed sub-urethral tape procedures, the objective cure rates were 77% and 54%, at a median follow-up of one year or 24.5 months, respectively (19,20). Nitahara et al. studied 60 patients with repeat Burch colposuspension procedure. Success results defined as satisfaction of more than 80% (questionnaire) and the use of one or no pad daily, were reported by 41 patients (69%) (21).
Midurethral sling procedures Twenty four studies on MUS for recurrent SUI reported a total of 858 cases, with a 68.5% pooled success rate (95%CI: ±3.11) (15,22-44). Amaye-Obu et al. studied two different sling surgical techniques for recurrent SUI, the combined abdominovaginal polypropylene sling (n = 70; group 1) and the modified urethral Marlex sling (n = 68; group 2). The objective cure rates were as high as 69% and 89% and the and subjective rates 66% and 96%, for groups 1 and 2 respectively, after six years follow-up (15). A recent study by Abdel-Fattah et al. reported outcomes in 46 women with recurrent SUI (31 patients had a failed MUS), following a secondary transobturator MUS. The overall subjective and objective success rates in this group were 70% and 77%, respectively (22). Higher objective success rates have been reported by Rezapour et al. (82%) and Kuuva et al. (89.6%) (23,24).
Success rates of MUS after failed Burch colposuspension range between 57.1-70.8%. However, these studies included only 29 and 24 women, respectively, or 53 in total, with a This article is protected by copyright. All rights reserved.
64.2% pooled success rate, (95%CI: ±3.64) (25,26). A 25% incidence of bladder injuries was reported by Shao et al. (26). Two small studies on MUS after failed bulking injections have
Accepted Article
shown 81% and 100% success rates on short-term follow-up (2 weeks, 3 of whom up to 6 months.
Not reported
TVT Cured: 46% (5) Improved: 46% (5)
±29,43 (TVT)
Accepted Article
Hassona h S. 2013[44]
22 cases
2b
Moderate
MMK: 1 Burch colposuspensi on: 2 Endoscopic bladder neck suspension: 2 MUS: 18
TVT 15 TOT 7
Retrospective study Small sample size Relatively short follow-up in some subjects.
Objective cure: was defined as having negative cough stress testing, performed with a subjectively full bladder in the supine and standing positions. Subjective cure: having no subjective leaking during stressful activities, such as coughing, laughing, sneezing, or exercising.
Objective
Objective cure 73% TVT 86% TOT Subjective cure 60% TVT 57% TOT
MMK: 4 Burch colposuspensi on: 15 Endoscopic bladder neck suspension: 3 MUS: 6
Laparoscopic two-team sling procedure
Retrospective study Small sample size Relatively short follow-up in some subjects.
Objective cure: was defined as having negative cough stress testing, performed with a subjectively full bladder in the supine and standing positions. Subjective cure: having no subjective leaking during stressful activities, such as coughing, laughing, sneezing, or exercising.
Objective
Objective cure: ±11,04 92% Subjective cure: 79%
±22,39 ±25,93
Voiding dysfunction 16 months requiring CISC: 1 (1-63) for (TOT) women in the TVT No other significant group complications associated with 15 months TVT or TOT (2-30) for insertion were the TOT reported. group
Laparoscopic 2 team sling procedure Hassona h S. 2013[44]
24 cases
2
Moderate
Pubovaginal slings Polypropylene pubovaginal slings
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Persisting voiding dysfunction necessitating prolonged CISC: 1 Infected hematoma: 1 Herniated small bowel at a laparoscopic port site: 1
25 months (1.5 to 60 months)
Accepted Article
Morgan JE 1995 [47]
88 cases
4
Low
Previous failed vaginal or retropubic procedures excluding hysterectomy
Two teams, 1 abdominally and 1 vaginally approach using a wide band of inert polypropylene (Marlex) mesh.
Retrospective study. Does not distinguish the success rates between the 2 groups, (abdominal and vaginal approach) and the index procedures.
Cured: no incontinent episodes, voiding symptom or erosion.
Retrospective study. Very small sample size.
UDS
Patient reported
Cured: 75 (85%)
±7,42
Urinary retention: 6 4.1 years (temporary in 4). Retention persisted for 2 years: 1 Persistent obstruction at 6 years: 1 Uncomplicated UTI: 5 (not recurrent) Suprapubic hematomas that resolved spontaneously: 2 Postoperative Dyspareunia: 2
±14,49
Postoperative suprapubic pain: 8 Voiding problems: 1
Improved: 8 (9%) (mainly UUI)
Improved: occasional SUI, urgency or sensation of incomplete voiding reported by the patient or demonstrated clinically.
Failed: 5 (6%)
Pubovaginal slings with autologous rectus fascia (RFS) Kane L. 1999 [48]
13 cases
4
Low
Pubovaginal sling Anterior colporrhaphy: 5 Colposuspensi on: 3 Pereyra/vagin al needle suspension: 11
This article is protected by copyright. All rights reserved.
Objective
Cured: 12/13 All 13 patients were subjectively continent
19-38 months
Accepted Article
Petrou SP. 2001 [49]
Shapiro A. AC. 2010 [43]
14 cases
25 cases (14 treated with RFS and 11 with TVT)
4
4
Low
Low
Pubovaginal sling with autologous fascia: 3 Pubovaginal sling with cadaveric fascia: 3 Bone anchored suburethral sling using cadaveric fascia: 5 Vaginal patch sling: 3
Pubovaginal sling
MUS
RFS 14 TVT 11
Retrospective study. Very small sample size.
Retrospective study. Supplement. Very small sample size. Time of follow up is not reported.
Blaivas-Groutz antiincontinence surgery response score
Cure: subjective absence of any symptoms of SUI. Improvement: at least a 50% reduction in symptoms of SUI.
Bulking injections Macroplastique® and Durasphere® injections
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Objective
Patient reported
Cured: 50% ±26,19 (7/14) (Blaivas-Groutz score 0). Good, fair and poor response with a BlaivasGroutz score of 2, 3 or 4 and 5 in 1 (7%), 4 (29%) and 2 (14%) patients, respectively. The response rate was similar when comparing treatment results of anterior rectus fascia and tensor fascia lata. RFS Cured: 86% (12) Improved: 14% (2) TVT Cured: 46% (5) Improved: 46% (5)
±18,34 (RFS) ±29,43 (TVT)
No intraoperative complications.
17 months (range 541)
Long-term urinary retention: 1 (7%) Pelvic abscess: 1 Osteomyelitis pubis: 1
Operative times & hospital stay were significantly longer in the RFS group. 7 (50.0%) RFS patients were discharged with catheters compared with 4 (36.4%) TVT patients. Time to normal voiding was significantly longer in the RFS group, with 5 patients requiring CISC for >2 weeks, 3 of whom up to 6 months.
Not reported
Accepted Article
Kim J. 2012 [50]
Lee HN. 2010 [51]
56 cases
23 cases
4
4
Low
Low
MUS
Durasphere, bulking agent
TVT, TOT
Macroplastique and Durasphere bulking agent
Retrospective study. Supplement
Retrospective chart review. Small sample size and follow-up time frame. The success rate is evaluated according to the subjective response only using questionnaires.
Success: ≤1 SUI episode/ week or ≥70% patientperceived improvement.
Sandvik questionnaire. Subjective cure was defined as no SUI in the past 7 days. The Subjective Symptom VAS (0=none, 10=unbearable) was used for the severity of SUI symptoms.
Periurithral fat injections
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Patient reported
Patient reported
Success: 39% (22/56) Failure: 61% (34/56). 34% (19/56) had slings placed for Durasphere failures at an average time of 18.3 months after injection Cure rate 35% Improvement 92% 77% of the patients were satisfied.
±12,79
Not reported
64.3 months
±19,47
Need for CISC: 4 10 months patients for less than 3 days. All patients were able to empty their bladder without significant residuals within a week of the injection.
Accepted Article
Su TH. 1998 [52]
26 cases
4
Low
Anterior repair: 16(61.6%) Stamey operation: 7(26.9%) Laparoscopic colposuspensi on: 1(3.8%) Burch colposuspensi on: 2(7.7%)
Periurethral fat injection
Retrospective study. The follow up of this study was relatively brief and the number of patients small.
Pad test UDS Cure: The patient being dry by the end of the follow up period, as documented by a 1hour extended pad test and UDS. Significant improvement: patients experiencing only rare, minimal leakage and who were personally satisfied with the results of the operation by third party questioning.
ACT and adjustable slings
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Objective
Success: 50% (13/26) Improvement: 15% (4)
±19,22
6 cases of immediate complications (23%). Dysuria: 1 Voiding difficulties: 2 Gross haematuria: 1 Lower abdominal pain: 1 UTI: 1 All complications resolved by 3 months postoperatively. There was 1 case with DO that persisted postoperatively. (Total late complication rate of 3.8%.)
17.4 months (12 to 30)
130 cases
Aboseif SR. 2011 [54]
77 cases
Accepted Article
Aboseif SR. 2009 [53]
2b
2b
Moderate
Moderate
Burch colposuspensi on: 73 MUS: 94 Bulking injection: 47 (At least 1 prior unsuccessful incontinence surgery)
ACT
Bulking agents: 25 (28%) MUS: 64 (72%) Suspension: 44 (49%) Burch colposuspensi on: 6 (6.7%) Artificial urinary sphincter: 1 (1.1%) Other: 1 (1.1%)
ACT In 77,9% cases re-adjusted
Prospective study. 162 total cases had undergone adjustable MUS implantation. Follow up data for 1 year were available on 140 patients. Of the implanted patients 84% (136 of 162) had previously undergone at least 1 prior unsuccessful incontinence surgery. Not all the patients had recurrent SUI.
Pad test
89 total cases had undergone adjustable MUS implantation. Follow-up at 1 year was available for 77 patients. No consecutive cohort.
Pad test
Objective
Cure: 52% (67/130) Improved: 80%
±8,59
Objective
Cured: 47% Improved: 92%
±11,15
Cure: less than 2 gm on provocative pad weight testing Improved: greater than 50% reduction on provocative pad weight testing.
Dry:
Accepted Article
Accepted Date : 10-Feb-2015 Article type
: Review Article
The surgical management of recurrent stress urinary incontinence: a systematic review
Running headline: The surgical management of recurrent SUI
Kostis I. Nikolopoulos1, Cornelia Betschart2 & Stergios K. Doumouchtsis1
1
Urogynaecology Unit, Department of Obstetrics and Gynaecology, St. George’s Healthcare
NHS Trust, St George’s University of London, London, UK 2
Department of Gynecology, University Hospital Zurich, Zurich, Switzerland
Corresponding Author: Kostis I. Nikolopoulos Urogynaecology Unit, Department of Obstetrics and Gynaecology, St. George’s Healthcare NHS Trust, St George’s University of London, Cranmer Terrace, London SW17 0RE, UK Email: [email protected]
Conflict of interest: This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/aogs.12625 This article is protected by copyright. All rights reserved.
K. Nikolopoulos and C. Betschart declare no conflict of interest. S. Doumouchtsis has received speaker honoraria and honoraria for participation in scientific meetings from
Accepted Article
Astellas, Pfizer and Speciality European Pharma, and has been a member of the advisory board of Speciality European Pharma.
Abstract Background: Despite a wide spectrum of interventions, surgical treatments of recurrent stress urinary incontinence (SUI) are associated with high failure rates. Objectives: To systematically review current evidence on the effectiveness of surgical interventions for recurrent SUI. Data sources: An electronic database search was undertaken (1980-2014). Keywords were: 'stress urinary incontinence', 'failure', 'recurrence', 'treatment'. References of identified studies and abstracts from conferences were considered. Study selection: We restricted the search to female patients and currently used surgical procedures, including studies with ≥5 cases. After the initial yield, studies were selected following title screening, abstract and full text scrutiny. Results: The pooled objective cure rates of colposuspension for recurrent SUI are 76% (95%CI: ±5.04), whereas rates for midurethral sling procedures are 68.5% (95%CI: ±3.11). Repeat midurethral sling procedures have pooled success rates of 66.2% (95%CI: ±4) but those of the transobturator approach appear lower than retropubic procedures. Pubovaginal slings for recurrent SUI, have pooled success of 79.3% (95%CI: ±6.54). Success rates for adjustable continence therapy and adjustable slings for recurrent SUI are 53.8% (95%CI: ±5.28), whereas for midurethral sling procedures fixation the pooled success is 61% (95%CI: ±10.56). Urethral bulking injections have success rates of 38% (95%CI:±10.7). Laparoscopic two-team sling procedures, salvage spiral slings and artificial urinary sphincter have shown promising results, but there is limited data on recurrent cases. Conclusion: There is a wide spectrum of surgical interventions reported for secondary or tertiary treatment of SUI. A common characteristic for all recurrent procedures is a lower success rate compared to those reported following primary procedures.
Keywords: stress urinary incontinence, midurethral sling, failure, recurrence, treatment.
Abbreviations and Acronyms
This article is protected by copyright. All rights reserved.
Adjustable Single-Incision Sling System
CI
confidence intervals
GRADE
Grading of Recommendations Assessment, Development, and Evaluation
MUS
midurethral sling procedures,
OCEBM
Oxford Centre for Evidence-based Medicine Levels of Evidence
SUI
stress urinary incontinence,
TOT
transobturator tape outside in,
TVT
tension-free vaginal tape,
TVT-O
transobturator tape inside out,
Accepted Article
AJUST®
Key Message Several different procedures can be considered for recurrent stress urinary incontinence, however, they are associated with lower success rates than those of the first surgery.
Introduction
The reported prevalence of stress urinary incontinence (SUI) can be as high as one in five adult women and approximately half of all incontinent women are affected by this type of incontinence (1). Many surgical procedures are used for the treatment of SUI. In spite of the wide spectrum of options available, treatment fails in 10-20% of patients (2). In the United States alone, about 120 000 women undergo surgery for urinary incontinence each year (3), so the expected absolute numbers of women with failures and recurrences as well as recurrent procedures are high. The persistence of symptoms after surgery for recurrent SUI is common. Since the introduction of the tension-free vaginal tape (TVT) in 1995, more than 1 200 000 procedures have been performed worldwide (4). However, the treatment of recurrent SUI after failed midurethral sling procedures (MUS) is a challenging problem. Although several studies have been published, to date there is no general consensus on the procedure of choice for treating recurrent SUI. A Cochrane review has recently evaluated the treatment of recurrent SUI after failed minimally invasive synthetic suburethral tape placement and found that there are no data to recommend or refute any of the different management strategies for recurrent or persistent SUI after failed suburethral tape surgery (5). In a recent meta-analysis from Agur et al., TVT and transobturator tape outside in (TOT) showed similar patientreported and objective cure rates for the treatment of recurrent SUI and both interventions This article is protected by copyright. All rights reserved.
had a comparable risk of further surgical procedures (6). We aimed to evaluate the current literature on the outcomes of secondary procedures, for the management of recurrent SUI
Accepted Article
after different types of primary surgical procedures.
Material and methods
Sources An electronic search strategy was developed for medical literature databases, the Cochrane Library 2014, PubMed (1950–2014), and Embase (1980–2014), and all searches were updated in May 2014. Google, Google Scholar and congress proceedings were also searched till 05/2014. The keywords and combinations that were used were ‘stress urinary incontinence’, ‘recurrence’, ‘treatment’ and ‘failure’. In addition, references of articles identified were checked for eligibility. We restricted the search to humans and female patients, but no other filters were applied. We also excluded studies involving not currently used surgical procedures. Studies that were finally selected for inclusion were evaluated on the basis of their methodological quality and time of follow-up. We did not specify any limit for the duration of follow-up. In our study design we followed the PRISMA guidelines for systematic reviews and we ensured compliance by completing the PRISMA checklist (7). We further assessed the quality of the selected studies using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria (8).
In order to diminish the subjectivity of the assessment of studies as much as possible, two authors (K.N. and C.B,) classified the quality of evidence independently. Any discrepancies were discussed and if no agreement could be reached, the third author (S.D.) made the final decision.
The objective of this article was to evaluate the success rates following surgical management of recurrent SUI. We undertook a systematic review of the literature and assessment of methodological quality of the qualifying studies. The significant heterogeneity of the selected studies, and the variation in the outcome measures did not allow us to undertake a metaanalysis.
Study selection was undertaken in three stages. First, the titles and then the abstracts of all retrieved articles were examined independently by the researchers. We subsequently This article is protected by copyright. All rights reserved.
examined the full text of each article, and for inclusion, we used an arbitrary cut-off of articles with at least five cases reported. The third step was scrutiny of full-text articles where
Accepted Article
inclusion criteria were met. Reference lists of these studies were also reviewed to identify any publications missed from the initial search (Figure 1).
Data extraction Information was extracted from each included study on: 1) number of cases and characteristics of trial participants, the level of evidence (Oxford levels, see below) and quality of evidence assessment (GRADE), 2) type of initial and secondary intervention, 3) internal bias, 4) type of outcome measure, defined in objective outcome parameters or patient-reported parameters or both, 5) success rates, while 6) 95% confidence intervals (CI) for proportions were calculated for each study, as well as 7) complication rates and 8) time of follow-up (Table 1).
Trial characteristics, outcome measures, success rates, complication rates and follow-up times, based on the Cochrane risk of bias tool, were independently extracted. The high heterogeneity of the retrieved data, as evident in Table 1, restricted the analysis.
Studies, reporting on outcomes of surgical treatment for recurrent SUI with insufficient information for assessment, especially on success rates, have been excluded. A number of randomized controlled trials on surgical management of SUI, which reported on the outcome of surgical management of recurrent SUI, were not included, because these publications did not specify which of the cases were recurrent and therefore identification of such cases or pooling of data was not possible (9-13).
Quality assessment Articles meeting the selection criteria were assessed for methodological quality, level of evidence (Oxford Centre for Evidence-based Medicine Levels of Evidence (OCEBM) www.cebm.net/oxford-centre-evidence-based-medicine-levels-evidence-march-2009/)), including factors likely to influence results. The 95%CI was calculated for each study as well as for pooled results. Factors assessed included prospective design, consecutive recruitment, adequate description of cases included and procedures undertaken, complete reporting of outcomes, complications and time of follow-up (Table 1). In addition we assessed the included studies with the following criteria, based on the GRADE approach which is This article is protected by copyright. All rights reserved.
considered by several organizations as a methodologically rigorous, user-friendly grading system (14). According to GRADE, the quality of evidence is divided into four categories:
Accepted Article
high, moderate, low, and very low. For each study, evidence quality was assessed according to GRADE and included five domains: study design, risk of bias, inconsistency, indirectness and imprecision. Because all the studies included in this review are observational studies, the initial assessment was ‘low’ level of quality.
Risk of bias was assessed for each study, taking into account the time of follow-up, and the outcome measures-definition of success. Objective outcome parameters are the cough test, no urinary leakage during urodynamics or different kinds of pad tests. Subjective or patientreported outcome parameters were the severity and impact of incontinence symptoms assessed by specific questionnaires.
The third domain, inconsistency, was also described as heterogeneity of results without a plausible explanation, based on differences in populations, interventions or outcomes. When group differences appeared (such as studies which do not report exact numbers of patients who had undergone an initial procedure when the initial procedure was variable, or which MUS were used, i.e. TVT or TOT), the quality rating was downgraded.
Indirectness could refer to indirect comparisons. As we did not include studies comparing two different interventions for the surgical management of recurrent SUI, indirectness was not applicable in this review.
The fifth domain, imprecision of results, referred to wide 95%CIs as a consequence of few participants or few events. The quality of evidence was downgraded in the case of a nonsignificant result (8).
Results
Our review revealed a wide spectrum of surgical techniques used for secondary or tertiary treatment of recurrent SUI. Procedures such as Burch colposuspension, retropubic MUS (TVT), transobturator tapes (TOT, transobturator tape inside out (TVT-O)), bladder neck injections and artificial urethral sphincter, have most commonly been reported (Table 1). This article is protected by copyright. All rights reserved.
Burch colposuspension
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Seven studies on Burch colposuspension for recurrent SUI have reported in total 276 cases, with a 76% overall success rate (95%CI: ±5.04) (15-21). According to Amaye-Obu et al. who studied 26 patients, the Burch procedure had a cure rate of 81% (95%CI: ±15.08) when it was carried out after one previous failed procedure (any procedure), 25% when it was done after two previous surgeries, and 0% after three previous procedures at a two year follow-up. They suggested that the Burch procedure should be avoided after more than one previous operation (p=0.001) (15). Similar success rates were reported by Maher et al. for Burch colposuspension after various index procedures, with objective cure rates of 81.1% (43/53 patients) (16). Two other studies on open colposuspension for failed continence procedures reporte objective and subjective cure rates to be 78 - 80% and 71 - 80%, respectively (17,18).
In two small retrospective studies of 13 and 16 patients who underwent open and laparoscopic Burch colposuspension after failed sub-urethral tape procedures, the objective cure rates were 77% and 54%, at a median follow-up of one year or 24.5 months, respectively (19,20). Nitahara et al. studied 60 patients with repeat Burch colposuspension procedure. Success results defined as satisfaction of more than 80% (questionnaire) and the use of one or no pad daily, were reported by 41 patients (69%) (21).
Midurethral sling procedures Twenty four studies on MUS for recurrent SUI reported a total of 858 cases, with a 68.5% pooled success rate (95%CI: ±3.11) (15,22-44). Amaye-Obu et al. studied two different sling surgical techniques for recurrent SUI, the combined abdominovaginal polypropylene sling (n = 70; group 1) and the modified urethral Marlex sling (n = 68; group 2). The objective cure rates were as high as 69% and 89% and the and subjective rates 66% and 96%, for groups 1 and 2 respectively, after six years follow-up (15). A recent study by Abdel-Fattah et al. reported outcomes in 46 women with recurrent SUI (31 patients had a failed MUS), following a secondary transobturator MUS. The overall subjective and objective success rates in this group were 70% and 77%, respectively (22). Higher objective success rates have been reported by Rezapour et al. (82%) and Kuuva et al. (89.6%) (23,24).
Success rates of MUS after failed Burch colposuspension range between 57.1-70.8%. However, these studies included only 29 and 24 women, respectively, or 53 in total, with a This article is protected by copyright. All rights reserved.
64.2% pooled success rate, (95%CI: ±3.64) (25,26). A 25% incidence of bladder injuries was reported by Shao et al. (26). Two small studies on MUS after failed bulking injections have
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shown 81% and 100% success rates on short-term follow-up (2 weeks, 3 of whom up to 6 months.
Not reported
TVT Cured: 46% (5) Improved: 46% (5)
±29,43 (TVT)
Accepted Article
Hassona h S. 2013[44]
22 cases
2b
Moderate
MMK: 1 Burch colposuspensi on: 2 Endoscopic bladder neck suspension: 2 MUS: 18
TVT 15 TOT 7
Retrospective study Small sample size Relatively short follow-up in some subjects.
Objective cure: was defined as having negative cough stress testing, performed with a subjectively full bladder in the supine and standing positions. Subjective cure: having no subjective leaking during stressful activities, such as coughing, laughing, sneezing, or exercising.
Objective
Objective cure 73% TVT 86% TOT Subjective cure 60% TVT 57% TOT
MMK: 4 Burch colposuspensi on: 15 Endoscopic bladder neck suspension: 3 MUS: 6
Laparoscopic two-team sling procedure
Retrospective study Small sample size Relatively short follow-up in some subjects.
Objective cure: was defined as having negative cough stress testing, performed with a subjectively full bladder in the supine and standing positions. Subjective cure: having no subjective leaking during stressful activities, such as coughing, laughing, sneezing, or exercising.
Objective
Objective cure: ±11,04 92% Subjective cure: 79%
±22,39 ±25,93
Voiding dysfunction 16 months requiring CISC: 1 (1-63) for (TOT) women in the TVT No other significant group complications associated with 15 months TVT or TOT (2-30) for insertion were the TOT reported. group
Laparoscopic 2 team sling procedure Hassona h S. 2013[44]
24 cases
2
Moderate
Pubovaginal slings Polypropylene pubovaginal slings
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Persisting voiding dysfunction necessitating prolonged CISC: 1 Infected hematoma: 1 Herniated small bowel at a laparoscopic port site: 1
25 months (1.5 to 60 months)
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Morgan JE 1995 [47]
88 cases
4
Low
Previous failed vaginal or retropubic procedures excluding hysterectomy
Two teams, 1 abdominally and 1 vaginally approach using a wide band of inert polypropylene (Marlex) mesh.
Retrospective study. Does not distinguish the success rates between the 2 groups, (abdominal and vaginal approach) and the index procedures.
Cured: no incontinent episodes, voiding symptom or erosion.
Retrospective study. Very small sample size.
UDS
Patient reported
Cured: 75 (85%)
±7,42
Urinary retention: 6 4.1 years (temporary in 4). Retention persisted for 2 years: 1 Persistent obstruction at 6 years: 1 Uncomplicated UTI: 5 (not recurrent) Suprapubic hematomas that resolved spontaneously: 2 Postoperative Dyspareunia: 2
±14,49
Postoperative suprapubic pain: 8 Voiding problems: 1
Improved: 8 (9%) (mainly UUI)
Improved: occasional SUI, urgency or sensation of incomplete voiding reported by the patient or demonstrated clinically.
Failed: 5 (6%)
Pubovaginal slings with autologous rectus fascia (RFS) Kane L. 1999 [48]
13 cases
4
Low
Pubovaginal sling Anterior colporrhaphy: 5 Colposuspensi on: 3 Pereyra/vagin al needle suspension: 11
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Objective
Cured: 12/13 All 13 patients were subjectively continent
19-38 months
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Petrou SP. 2001 [49]
Shapiro A. AC. 2010 [43]
14 cases
25 cases (14 treated with RFS and 11 with TVT)
4
4
Low
Low
Pubovaginal sling with autologous fascia: 3 Pubovaginal sling with cadaveric fascia: 3 Bone anchored suburethral sling using cadaveric fascia: 5 Vaginal patch sling: 3
Pubovaginal sling
MUS
RFS 14 TVT 11
Retrospective study. Very small sample size.
Retrospective study. Supplement. Very small sample size. Time of follow up is not reported.
Blaivas-Groutz antiincontinence surgery response score
Cure: subjective absence of any symptoms of SUI. Improvement: at least a 50% reduction in symptoms of SUI.
Bulking injections Macroplastique® and Durasphere® injections
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Objective
Patient reported
Cured: 50% ±26,19 (7/14) (Blaivas-Groutz score 0). Good, fair and poor response with a BlaivasGroutz score of 2, 3 or 4 and 5 in 1 (7%), 4 (29%) and 2 (14%) patients, respectively. The response rate was similar when comparing treatment results of anterior rectus fascia and tensor fascia lata. RFS Cured: 86% (12) Improved: 14% (2) TVT Cured: 46% (5) Improved: 46% (5)
±18,34 (RFS) ±29,43 (TVT)
No intraoperative complications.
17 months (range 541)
Long-term urinary retention: 1 (7%) Pelvic abscess: 1 Osteomyelitis pubis: 1
Operative times & hospital stay were significantly longer in the RFS group. 7 (50.0%) RFS patients were discharged with catheters compared with 4 (36.4%) TVT patients. Time to normal voiding was significantly longer in the RFS group, with 5 patients requiring CISC for >2 weeks, 3 of whom up to 6 months.
Not reported
Accepted Article
Kim J. 2012 [50]
Lee HN. 2010 [51]
56 cases
23 cases
4
4
Low
Low
MUS
Durasphere, bulking agent
TVT, TOT
Macroplastique and Durasphere bulking agent
Retrospective study. Supplement
Retrospective chart review. Small sample size and follow-up time frame. The success rate is evaluated according to the subjective response only using questionnaires.
Success: ≤1 SUI episode/ week or ≥70% patientperceived improvement.
Sandvik questionnaire. Subjective cure was defined as no SUI in the past 7 days. The Subjective Symptom VAS (0=none, 10=unbearable) was used for the severity of SUI symptoms.
Periurithral fat injections
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Patient reported
Patient reported
Success: 39% (22/56) Failure: 61% (34/56). 34% (19/56) had slings placed for Durasphere failures at an average time of 18.3 months after injection Cure rate 35% Improvement 92% 77% of the patients were satisfied.
±12,79
Not reported
64.3 months
±19,47
Need for CISC: 4 10 months patients for less than 3 days. All patients were able to empty their bladder without significant residuals within a week of the injection.
Accepted Article
Su TH. 1998 [52]
26 cases
4
Low
Anterior repair: 16(61.6%) Stamey operation: 7(26.9%) Laparoscopic colposuspensi on: 1(3.8%) Burch colposuspensi on: 2(7.7%)
Periurethral fat injection
Retrospective study. The follow up of this study was relatively brief and the number of patients small.
Pad test UDS Cure: The patient being dry by the end of the follow up period, as documented by a 1hour extended pad test and UDS. Significant improvement: patients experiencing only rare, minimal leakage and who were personally satisfied with the results of the operation by third party questioning.
ACT and adjustable slings
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Objective
Success: 50% (13/26) Improvement: 15% (4)
±19,22
6 cases of immediate complications (23%). Dysuria: 1 Voiding difficulties: 2 Gross haematuria: 1 Lower abdominal pain: 1 UTI: 1 All complications resolved by 3 months postoperatively. There was 1 case with DO that persisted postoperatively. (Total late complication rate of 3.8%.)
17.4 months (12 to 30)
130 cases
Aboseif SR. 2011 [54]
77 cases
Accepted Article
Aboseif SR. 2009 [53]
2b
2b
Moderate
Moderate
Burch colposuspensi on: 73 MUS: 94 Bulking injection: 47 (At least 1 prior unsuccessful incontinence surgery)
ACT
Bulking agents: 25 (28%) MUS: 64 (72%) Suspension: 44 (49%) Burch colposuspensi on: 6 (6.7%) Artificial urinary sphincter: 1 (1.1%) Other: 1 (1.1%)
ACT In 77,9% cases re-adjusted
Prospective study. 162 total cases had undergone adjustable MUS implantation. Follow up data for 1 year were available on 140 patients. Of the implanted patients 84% (136 of 162) had previously undergone at least 1 prior unsuccessful incontinence surgery. Not all the patients had recurrent SUI.
Pad test
89 total cases had undergone adjustable MUS implantation. Follow-up at 1 year was available for 77 patients. No consecutive cohort.
Pad test
Objective
Cure: 52% (67/130) Improved: 80%
±8,59
Objective
Cured: 47% Improved: 92%
±11,15
Cure: less than 2 gm on provocative pad weight testing Improved: greater than 50% reduction on provocative pad weight testing.
Dry:
